FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Can Regulation (Really) Encourage Innovation? The FDA, Continuous Manufacturing, & Patient Safety
    Can Regulation (Really) Encourage Innovation? The FDA, Continuous Manufacturing, & Patient Safety

    A diverse group of industry veterans discuss ways in which the FDA encourages innovation, what role the agency’s Emerging Technology Team (ETT) plays in supporting manufacturing innovation, and whether the regulator’s innovation-safety balance is (or should be) the same for rare or orphan disease treatments as it is for blockbuster drugs.

  • 7 Surefire Ways To Motivate A Life Science Consultant
    7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  • CMS’ Decision On Coding For Biosimilars: A Deeper Look
    CMS’ Decision On Coding For Biosimilars: A Deeper Look

    The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive? As the decision is applauded by various prescriber, patient, and industry groups, it is key to investigate the events that could ensue from the decision, and whether it will stimulate the U.S. biosimilar industry, which languishes behind that of other geographies.

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PHARMA OUTSOURCING WHITE PAPERS

The Race to Phase III: A Cautionary Tale of Scalability The Race to Phase III: A Cautionary Tale of Scalability

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

Insights And Tips When Addressing Bioburden Challenges Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Continuous Processing Optimization With Smarter Tools

Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.

Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

Fundamentals Of Spray-Dried Dispersion Technology

A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Vertex Pharmaceuticals: Document Management Strategies For R&D

Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.

Capsule Dosing Techniques For Dry Powder Inhalers

Dry powder inhaler (DPI) devices that utilize two-piece capsules as the dose-holding system can require specialized dosing equipment to fill the capsules. Such products are known as "premetered."

Integrate A Mixing System As A Slurry Tank When Packing Chromatography Columns

This application note describes the performance of single-use Xcellerex XDM Quad Mixing System used as a slurry tank when packing chromatography columns. The capability of the mixing system to keep the chromatography medium (resin) in suspension and the possibility to integrate the system in column packing were studied. The results show that XDM Quad Mixing System is suitable for use as a media slurry tank when packing chromatography columns.

Are You Into Biosimilars?

Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

Data Analytics for Pharma Development November 28 - 30, 2017
Brussels)
Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
An Introduction to Good Laboratory Practices (GLP) December 5, 2017
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training)
Duration:  90 minutes
Price:  $299 - Introductory Rate
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